Lead complex regulatory publishing projects from Canada with advanced eCTD software and rigorous document quality control. Work remotely within a global clinical research environment. As Principal Regulatory Operations Publisher, you will independently prepare and finalise electronic regulatory submissions. You will coordinate with Medical Writing, Biostatistics, Programming, and Regulatory Affairs teams. The role also includes technical guidance, mentoring, and expert support for publishing challenges across oncology and rare disease programmes. Key Responsibilities:

Lead regulatory publishing projects from planning through completion Finalise, format, quality-control,



and publish electronic submissions Coordinate multidisciplinary teams to ensure submission readiness Manage complex regulatory dossiers and submission amendments Support FDA, EMA, and post-marketing regulatory submissions Requirements:

Bachelor's degree, preferably in a scientific discipline At least eight years of relevant regulatory publishing experience Advanced Adobe Acrobat, ISIToolbox, and regulatory software proficiency Robust Microsoft Word styles, templates, and EndNote familiarity Excellent English communication, leadership, and problem-solving skills Apply regulatory publishing expertise, eCTD knowledge, and cross-functional leadership to support compliant global clinical submissions.

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📌 Principal Regulatory Publishing Lead (Winnipeg)
🏢 Jobgether
📍 Winnipeg